Gaining certification from Lachman Consultants, an independent GMP consultancy, is a step towards KV being allowed to resume shipping of its products. KV has ceased shipping until it can satisfy measures detailed in its consent decree with the US Food and Drug Administration (FDA).

Lachman conducted the inspection of the facility during the week commencing April 19 and reported that operations are in compliance with GMP. KV is now “working diligently” to manufacture a product under the newly certified GMP systems for certification by Lachman.

Production of validation batches is expected to begin in May. If Lachman certifies the product the FDA will conduct its own inspection of KV’s facilities, systems and processes. The agency will also inspect the Lachman certified product.

Successful completion of the FDA inspection will lead to KV being allowed to resume shipping. This is unlikely to occur until the fourth quarter of the calendar year at the earliest, according to KV.

Job losses

At the end of March KV laid off 289 employees, which represented 42 per cent of its workforce, to lower its operating costs as its attempts to manage its finances during a difficult period.

David Van Vilet, interim CEO of KV, said: “Despite this reduction in our work force, we believe we have retained the capabilities and the overall level of employees needed to effectively support our future re-entry into the market.”